Effects of vaporised cannabis, with and without CBD, on driving and cognitio

Completed

• Conditions: niet van toepassing

• Registration Number: NL-OMON47963
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

* Occasional cannabis users (>10 lifetime exposures and <2x/week in the last 12 months)
* Age between 20-50
* Good physical health as determined by medical examination and laboratory analysis
* Absence of any major medical, endocrine and neurological condition
* Normal weight, body mass index (weight/height2) between 20 and 28 kg/m2
* In possession of a valid driver license with at least 2 years driving experience (having driven > 3000 km/yr)
* Written Informed Consent

Exclusion Criteria

* History of drug abuse (other than the use of cannabis) or addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
* Pregnancy or lactation (pregnancy test, if needed)
* Hypertension (diastolic> 90; systolic> 140)
* Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
* Liver dysfunction
* Use of medications that may impact upon driving ability (e.g. mood stabilisers, sedatives)
* Any serious prior adverse response to cannabis
* History of cardiac dysfunctions (e.g. arrhythmia, ischemic heart disease)
* QT syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Driving performance will be assessed using the on-road driving test. Outcome<br /><br>measures will include standard deviation of lateral position (SDLP), speed (MS)<br /><br>and standard deviation of speed (SDSP).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(1) Cognitive performance as assessed using the Divided Attention Task (DAT),<br /><br>Digit Symbol Substitution Task (DSST), Paced Auditory Serial Addition Task<br /><br>(PASAT), Tower of London (TOL) task;<br /><br>(2) Subjective drug effects and confidence in driving ability as measured by a<br /><br>series of Visual Analog Scales (VAS); Cannabis effects on anxiety as measured<br /><br>by the State Trait Anxiety Inventory (STAI) and an emotional Stroop task,<br /><br>(3) Plasma concentrations of THC, 11-OH-THC, THCCOOH and CBD.</p><br>